About this trial
Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mothers will be English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)
Maternal consent must be provided for infants.
Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.
no chronic inflammatory conditions that require long-term systemic immunosuppressive medications in first or second trimester
Disqualifiers
Inability or unwillingness of subject to give written informed consent or comply with study protocol.
Known history of renal/liver/cardiac insufficiency in the mother or infant.
Pregnant women with PN or egg allergy.
Pregnant women who refuse to eat PN (or peanut products) and/or eggs.
Trial design
Parallel
Treatments tested in this trial
Consumption
BehavioralSubjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
Avoidance
BehavioralSubjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
Treatment groups
Trial outcomes
Primary outcomes
Egg or peanut sensitization
Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).
Secondary outcomes
Peanut and egg specific IgG and IgG4
Levels of infant peanut and egg specific IgG and IgG4
Antibodies in maternal blood
Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy and at four months.
Egg allergy
Questionnaire for parents to report any signs of egg allergy in their child.
Egg and peanut specific IgE
Measure levels of infant egg- and peanut-specific IgE.
Other outcomes
Exploratory: Peanut sensitization
The proportion of high-risk infants who have developed peanut sensitization
Exploratory: Egg sensitization
Proportion of infants who develop egg sensitization.
Exploratory: Symptoms
Questionnaire for parents to report symptoms of non-IgE mediated food allergy
Exploratory: Peanut sensitization 12 months
Questionnaire for parents to report signs of peanut allergy
Sponsors and contacts
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University of Rochester
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator